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NCT04797637 · ClinicalTrials.gov registry record · NA

Post-operative Patient Positioning Device for Improvement of Post-Operative Pain

A NA study, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
NA
Development phase
278
Enrollment target

NCT04797637 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 278 participants.

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The verdict

NCT04797637, a NA study, has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
NA
Development phase
278 participants
Enrollment target

Study Summary

This paucity of evidence supporting or dissuading the use of postoperative abdominal support following cesarean section for the reduction of postoperative pain leaves important clinical questions unanswered. Additionally, there is an absence of long-term outcomes associated with the use of abdominal support devices. There remains a need for the development and implementation of nonpharmacologic methods for analgesia for women following cesarean sections, along with evidence-based recommendations regarding their use in postoperative patients. The ABBy (G-Squared Medical, Brentwood, TN) is an extended-wear panniculus retractor/tissue stabilizer that is intended for use postoperatively after abdominal procedure. It is placed directly onto patient skin, superior to a transverse incision, and is then used to elevate redundant tissues away from an incision or wound (https://www.gsquaredmedical.com/How-it-Works.html). The ABBy can be removed and replaced by patients and can be used for up to 10 days. This study aims to assess the effect of ABBy use on postoperative pain, pain medication requirement, and patient satisfaction, when used as a patient-positioning device in women following cesarean delivery.

Interventions

  • DEVICE ABBy® Adjustable Panniculus Retractor for Wound Care

Trial Details

FieldValue
Enrollment Target 278 participants
Start Date 2021-04-01
Est. Completion 2022-07-20
Phase NA

What the Registry Record Tells You About NCT04797637

The ClinicalTrials.gov registry entry for NCT04797637 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 278 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which ABBy® Adjustable Panniculus Retractor for Wound Care is the first listed.

NCT04797637 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04797637 about?

NCT04797637 is a clinical study titled "Post-operative Patient Positioning Device for Improvement of Post-Operative Pain". This paucity of evidence supporting or dissuading the use of postoperative abdominal support following cesarean section for the reduction of postoperative pain leaves important clinical questions unanswered. Additionally, there is an absence of long-term outcomes associated with the use of abdominal...

What is the current status of trial NCT04797637?

This trial is currently completed. It is a NA study. The enrollment target is 278 participants. The study started on 2021-04-01. Estimated completion is 2022-07-20.

What interventions are being tested in trial NCT04797637?

The interventions under investigation include: ABBy® Adjustable Panniculus Retractor for Wound Care (DEVICE).

Who is sponsoring clinical trial NCT04797637?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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